Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1

Phase 3

Terminated

Conditions: Neurotrophic Keratopathy

Interventions: Drug: RGN-259
Drug: Placebo

Registration Number: NCT02600429

Lead Sponsor: ReGenTree, LLC

Brief Summary: The objective of this study is to assess the safety and efficacy of RGN-259 Ophthalmic Solution compared to placebo for the treatment of NK.

Detailed Description: Neurotrophic keratopathy (NK) is a degenerative corneal disease that occurs as a result of partial or total impairment of trigeminal innervation. The resulting loss of corneal sensitivity (anesthesia) leads to a reduction in lacrimation and a decline in status, metabolism, and mitosis of corneal epithelial cells. Previous studies (physician-sponsored studies) used to treat to nine patients with NK, six of whom had discrete geographic, non-healing lesions, and three of whom had punctate lesions and the study result reported.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 18

Inclusion Criteria

Be male or female of any race, at least 18 years of age
Have provided verbal and written informed consent.
Be able and willing to follow instructions, including participation in all study assessments and visits;
Have stage 2 or 3 neurotrophic keratopathy in at least one eye If a female of childbearing potential, have a negative urine pregnancy test at Visit 1 and agree to use an adequate method of birth control throughout the study period.

Exclusion Criteria

Have any clinically significant slit lamp findings at Visit 1 that in the opinion of the investigator may interfere with the study parameters;
Have significant blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergy that requires treatment
Have a lid function abnormality (ex. Lagophthalmos) which, in the opinion of the investigator, is the primary cause of the persistent epithelial defect;
Be diagnosed with ongoing ocular infection (bacterial, viral or fungal) or active inflammation (e.g. follicular conjunctivitis) not related to NK
Anticipate the use of fluoroquinolone-containing antibiotic eye drops during the study;
Have used contact lenses (excluding therapeutic contact lenses) within 14 days prior to Visit 1 or anticipates use of contact lenses during the study period;
Have an uncontrolled systemic disease that in the opinion of the investigator may interfere with the study parameters;
Anticipate a change in immunosuppressive therapy during the course of the study;

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RGN-259	RGN-259	It is a preservative-free, sterile eye drop solution containing Tβ4
Placebo	Placebo	It is composed of the same excipients as RGN-259 but does not contain Tβ4.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Achieving Complete Healing at Day 29.	29 days after first dosing	Percentage of subjects achieving complete healing of the persistent epithelial defect as determined by corneal fluorescein staining at day 29 after first dosing.

Secondary Outcome Measures

Name	Time	Method
Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification.	8, 15, 22, 29, 36, 43 days after first dosing	Epithelial Defect Measurement and Classification as stage 1, 2 or 3 using Mackie Classification at 8, 15, 22, 29, 36, 43 days after first dosing
Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days	8, 15, 22, 36, 43 days after first dosing	Percentage of subjects achieving complete healing of the Persistent Epithelial Defect(PED) determined by corneal fluorescein staining at 8, 15, 22, 36, 43 days after first dosing.
Tear Film Break-up Time at 29, 36, 43 Days	29, 36, 43 days after first dosing	Tear Film Break-up Time at 29, 36, 43 days after first dosing
Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing	8, 15, 22, 29, 36, 43 days after first dosing	Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing at Visits 2, 3, 4, 5, 6, and 7 (The scale used to determine the difference in Ocular Discomfort by questionnaire on each visit is from 0(None) to 5(Most). This outcome was calculated from two time points as the value at the later time point minus the value at the first dosing points and the lower value are considered to be a better outcome. and the all relevant time points used in the calculation in the Time Frame was 8, 15, 22, 29, 36, 43 days.)
Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days	8, 15, 22, 29, 36, 43 days after first dosing	Visual acuity(logMAR) at 8, 15, 22, 29, 36, 43 days (The Visual acuity was assessed by LogMAR calculation method. In the case of the LogMAR method, Each letter has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units. and The lower value are considered to be a better outcome.) The formula used in calculating the score is: LogMAR VA = 0.1 + LogMAR value of the best line read - 0.02 X (number of optotypes read) used to determine the difference in Ocular Discomfort by questionnaire on each visit is the ORA scale: 0 None to 5: Most And as this outcome was calculated from two time points as the value at the later time point minus the value at the first dosing points, The lower value are considered to be a better outcome. and the all relevant time points used in the calculation in the Time Frame was 8, 15, 22, 29, 36, 43 days.)

Trial Locations

Locations (11): Insight Vision Group
🇺🇸
Parker, Colorado, United States
The Eye Care Institute
🇺🇸
Louisville, Kentucky, United States
Hull Eye Center
🇺🇸
Lancaster, California, United States
Richard Eiferman, MD, PSC
🇺🇸
Louisville, Kentucky, United States
Koffler Vision Group
🇺🇸
Lexington, Kentucky, United States
Vision Institute
🇺🇸
Colorado Springs, Colorado, United States
Eye Center of Northern Colorado
🇺🇸
Fort Collins, Colorado, United States
Medical Faculty Associates, Inc.
🇺🇸
Washington, District of Columbia, United States
Midwest Cornea Associates, LLC
🇺🇸
Indianapolis, Indiana, United States
Black Hills Regional Eye Institute
🇺🇸
Rapid City, South Dakota, United States
Central Maine Eye Care
🇺🇸
Lewiston, Maine, United States